On the Line

When investing in form-fill-seal machines, medical device and drug packaging professionals seek machinery that can help streamline their packaging operations. Given the size of the investment, these packagers need systems that can carry sizeable workloads reliably. High product volume may not be the only driver; users may need to run packaging, printing, inspection, and other functions all on one line, with minimal manual labor.

“The medical device industry wants machines that are easy to operate, maintain, and change over,” explains Ernie Newell, vice president and general manager of Ossid. “These machines must provide for fast, easy, and reliable integration with upstream and downstream systems.”

The PowerPak thermoformer range from CFS has now been extended by two compact machines for small production capacities.

For instance, “machines must be able to supply real-time data on production and machine status where and when it is needed,” Newell explains. As a result, “customers want intelligent machines that have seamless plug-and-play Ethernet connectivity. Ethernet connectivity and Pack ML programming help to answer the connectivity and integration requirements.”
To ensure fast changeover and improved precision, Ossid “includes an increased number of axes of control for horizontal form-fill-seal machines through servo drives,” Newell reports. Ossid installs all the information to run the machine on the machine, making operator manuals and trouble shooting scenarios available through a touch screen operator interface. “We ensure that data [are] available in the proper format and type for access by higher level management systems,” he adds.
Ossid has also been increasing the number and sophistication of real-time inspection systems for horizontal form-fill-seal machines, Newell reports.

Printing inline is also in demand. “In addition to safety features, the most important optional eqipment we offer to the medical device industry is our range of printers,” explains Stefan Krakow of CFS Germany GmbH. “Our portfolio includes rotary or platen press ink printers, some of them employing water-soluble inks even for printing on non-porous substrates, special rotary printers for in-line two-color print, thermal-transfer printers, and a variety of ink-jet printers ranging from the classical lower-resolution systems to setups containing desktop printer-type ink cartridges. The variety of solutions allows us to cover basically all printing demands typically required in the medical device industry.”

Machinery manufacturers are also working to bring the benefits of form-fill-seal to smaller operations. CFS has extended its PowerPak thermoformer range with two compact machines. “There is a trend in the industry toward smaller machines for dedicated production cells, running one product only,” explains Krakow. “These dedicated machines often tend to be smaller than the multifunctional packaging machines for a variety of products. Still, even the compact machines maintain the high standards, specifically in the sealing system, which our customers have come to expect from us.” Machine lengths start from about 3.80 meters, suiting the PowerPak range for smaller spaces, for producing packs with small dimensions, and for meeting small capacity and batch size requirements.

Contract Packager Growing with Multivac
Puracon (Rosenheim) is a contract packager specializing in handling medical devices. Products such as shoulder and hip joints, cardiac catheters, and dental instruments are assembled and packaged in a modern GMP-compliant cleanroom. To keep up with growing packaging volumes, Puracon installed last year a thermoform-fill-seal machine, the Multivac R 245 machine, in its cleanroon.
“In the sterile sector, we currently have more than 30 regular customers entrusting us with the packaging of their products,” says Jürgen Klein, founder and director of the packaging service provider, in a press release issued by Multivac. The company serves customers come from all over the world, including the United States.
Previously packaging products in just film pouches, Puracon found that increasing customer volumes called for an alternative. Thermoform packaging machines were considered, given their economic advantages in high packaging volumes over the long term. Klein reports that Puracon has since received volume orders from regular customers that make a thermoform packaging machine not only worthwhile, but even indispensable. “Last year we decided on a Multivac R 245 because we simply wanted the best manufacturer. We owe that to our customers all over the world,” he said in the release.
The R 245 is enabling Puracon to further expand its position as a leading contract packager. One project running soon on the
R 245 is a soft-film package of an infusion hose with enclosed OP scissors, in large volumes and in a size of 30 by 40 cm, Multivac reports.

As standardized as form-fill-seal machines can be, the medical and pharmaceutical industries are asking for machines tailored to their operations. “From a standard platform, we build custom machines. Every customer wants custom features,” says Newell.
Future work for Ossid includes focusing on predictive maintenance “because companies want to be able to do just-in-time maintenance,” says Newell. “Other important projects include developing inspection systems with additional capabilities, increasing safety for operators, and improving the sustainability of our machines in terms of lower material and energy costs.”

Product quality and safety remain top concerns. “The basic machine design has been optimized toward cleaning procedures,” says Krakow of CFS. “To what extent those are applied, is up to the individual customer. Safety in this context does not refer to our machines being safe to operate, which they of course are, as certified by independent inspection bodies. It is a reference to the high number of optional functions and devices we can employ in our machine design in order to ensure product safety and quality during the packaging process. One important aspect here is the quality of the produced pack, where features like seal quality and integrity can be surveilled. Other aspects are completeness of product loading or product positioning in the formed cavity. The scope of the desired safety functions is defined in a close dialogue with our customers.”

Flow wrapping
In today’s competitive environment, pharmaceutical and medical device companies are looking for more cost-effective packaging while maintaining product quality, reports Kevin Ryan of Formost Fuji Corp. The company offers machinery to produce hermetically sealed flowwrap packages where the films provide the barrier properties to protect their product, including use of aluminum foil–based films. “Climatic Zone 4 hot and humid environments have required the additional barrier to protect the product,” says Ryan. “Flowwrap HFFS machines are better equipped to handle a larger three-dimensional product of a foil package than a thermoformer.”

Formost Fuji has designed machines specifically for aluminum foil packages where the forming box is polished and has shallow angle suitable to wrap the foil around the product. More control is required to seal the package without fracturing the foil, Ryan says.

For instance, Fuji’s FW3400BSGM was designed specifically for foil barrier packages used in the pharmaceutical and medical device industries, Ryan reports. “This machine is designed for cGMP facilities with balcony design separating the clean and non-clean sections of the machine with no dead spots for product to get lost and accountability for all products. The BSGM is equipped with push button change over and digital scales to allow for a repeatable and quick change over. The ISO 11607 validation package reflects all of the Critical Quality Attributes (CQA) to control film feed without damage or wrinkles, position control, and sealing parameters. Sensors are used to detect any issues that would cause noncompliant packages, for example film alignment or product in the seal area.”

Formost Fuji provides standard machine design that is customized for each application. At Pack Expo Formost Fuji will be showing its patented seal bars on its rotary and box motion sealers as well as two new sealing technologies designed for the pharmaceutical and medical device industries. “The net result will be green technology with lower utility cost, lower material cost with stronger hermetic seals, and the fastest hermetic sealer on the market,” Ryan concludes.